NHP GMP GL 加拿大天然保健品的GMP生产规范.pdfVIP

GOOD MANUFACTURING PRACTICES GUIDANCE DOCUMENT Natural Health Products Directorate August 2006 Version 2.0 “Our mission is to help the people of Canada maintain and improve their health, while respecting individual choices and circumstances.” Health Canada “Our role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.” Natural Health Products Directorate Également offert en français sous le titre : Bonnes pratiques de fabrication document de référence This publication is also available electronically at the following address: www.healthcanada.gc.ca/nhp © Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2006. Cat. H164-26/2006E-PDF ISBN 0-662-44007-2 Contact the Natural Health Products Directorate Natural Health Products Directorate Health Canada 2936 Baseline Rd., Tower A Ottawa, Ontario K1A 0K9 www.healthcanada.gc.ca/nhp Telephone: 1-888-774-5555 Fax: (613) 948-6810 Email: NHPD_DPSN@hc-sc.gc.ca ABOUT THIS GUIDANCE DOCUMENT This guidance document is intended for manufacturers, packagers and labellers of natural health products (NHPs) in Canada and elsewhere, including Canadian importers and distributors of these products. It is meant to help them meet the good manufacturing practice (GMP) requirements of the Natural Health Products Regulations (the Regulations). In addition, the guidance document is a tool for the Quality Assurance Person (QAP) to implement and maintain GMP and to fulfill their role in assuring the quality of a NHP before it is made available for sale. It is the responsibility of the manufacturer, packager, labeller or importer to ensure that